Status:
UNKNOWN
Comparison of Two Different Diets on Health Outcomes
Lead Sponsor:
University of Virginia
Conditions:
Metabolic Syndrome X
Eligibility:
All Genders
18-64 years
Phase:
NA
Brief Summary
The purpose of this study is to compare the effects of a low-carbohydrate diet and a high-carbohydrate, high-fiber diet, on insulin sensitivity and blood chemicals considered risk markers for heart di...
Detailed Description
Low-carbohydrate eating is becoming perceived as more than just a weight loss diet, but rather a means to improve health. Several studies have been published suggesting that low-carbohydrate diets may...
Eligibility Criteria
Inclusion
- 1\. Subjects must meet the criteria of the metabolic syndrome, which is defined as having three or more of the following:
- Waist circumference: \>94 cm for males; \>80 cm for females
- Blood Pressure: \>130/85 mmHg
- HDL-Chol (mg/dl): \<50 women; \<40 men)
- Triglycerides (mg/dl): \>150
- Glucose (mg/dl): \>100 2. Subjects must meet age requirement 3. Subjects must be nonsmokers 4. Subjects must be willing to provide written consent 5. Subjects must be willing to pick-up up meals at the GCRC and return uneaten food 6. Have no food allergies 7. Subjects must not be currently following any particular diet, and must not have intentionally lost weight by dieting during the previous 3 months 8. Subjects must not be taking nutritional supplements other than a daily multivitamin 9. Subjects must be willing to maintain current physical activity routine, which cannot exceed the equivalent of \> 30 minutes per day of moderate-intensity activity 10. Blood hematocrit must be at least 40 for men and 36 for women.
Exclusion
- 1\. Does not meet the criteria for the metabolic syndrome 2. Does not meet age requirement 3. Smoker 4. Pregnancy 5. Food allergies 6. Unwillingness to provide written consent 7. Personal history of cardiovascular disease, including prior myocardial infarction, angioplasty, or bypass surgery 8. Known cardiovascular or metabolic diseases (e.g., diabetes) 9. Currently using medications to control blood pressure, lipids, or glucose 10. Currently on a diet or has attempted weight loss by dieting during the past 3 months 11. Currently taking nutritional supplements other than a daily multivitamin 12. Currently exercising more than the equivalent of 30 minutes/day of moderate-intensity physical activity 13. Currently on oral contraceptives 14. Hematocrit below 40 for men or below 36 for women 15. Baseline systolic blood pressure below 100 mmHg
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Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2009
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00269646
Start Date
November 1 2004
End Date
August 1 2009
Last Update
February 18 2009
Active Locations (1)
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1
University of Virginia General Clinical Research Center
Charlottesville, Virginia, United States, 22904